TraumaFASTNCT02289885
FAST Examination During Emergency Practice
A study testing SonoScape in people with Trauma and Ultrasonography, run by International Institute of Rescue Research and Education at 1 site in Poland.
Trial summary
The study evaluates the knowledge, attitude and practice about Focused Assessment with Sonography in Trauma among emergency medicine practitioners in Poland. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trauma, Ultrasonography
- What is being tested?
- SonoScape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Paramedics currently practicing in a Polish emergency department units and emergency medical services
- Age ≥ 18 years
Who cannot join
- Inability to participate in all aspects of the study prior to study begin
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
International Institute of Rescue Research and Education
Warsaw, 04-628
Lukasz Szarpak, +48500186225, lukasz.szarpak@gmail.com
Lukasz Szarpak
About this study
Official title: Knowledge, Attitude and Practice About Focused Assessment With Sonography in Trauma Among Paramedics. Randomized Crossover Manikin Trial
The study evaluates the knowledge, attitude and practice about Focused Assessment with Sonography in Trauma among emergency medicine practitioners in Poland.
- Conditions
- Trauma, Ultrasonography
- Being tested
- SonoScape
- Keywords
- trauma, examination, knowledge, paramedic
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonoScapeDevice
Also called SonoScape S6 Portable Ultrasound Machine
Ultrasonography device
| Study group | Role | What they receive |
|---|---|---|
| normal model patient | Experimental | Images of the ultrasound window were captured to disk and later evaluated by an expert in emergency medicine. In this study, the FAST examination was measured to the perihepatic space (also called Morison's pouch or the hepatorenal recess), perisplenic space, pericardium, and the pelvis. Receives: Device: SonoScape |
| ascites positive model patient | Experimental | Images of the ultrasound window were captured to disk and later evaluated by an expert in emergency medicine. In this study, the FAST examination was measured to the perihepatic space (also called Morison's pouch or the hepatorenal recess), perisplenic space, pericardium, and the pelvis. Receives: Device: SonoScape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tests of Knowledge of the FAST Examination
knowledge-based measures used to evaluate participants' knowledge of FAST-examination-related concepts (Survey)
Measured: 1 day
Secondary outcomes (4)
FAST Performance Test
The performance test required participants to conduct a FAST examination on two model patients (one normal, one ascites positive). No help or feedback was given to the participants.
Measured: 1 day
Window acquisition time
Identification of FAST Window Quadrants and Diagnostic Interpretation of FAST Windows.
The window acquisition time was measured with a stopwatch and represented the period between first contact of the probe with the model patient's body and when the participant said "stop" to indicate an adequate window or the participant's judgment that he or she could not acquire the window.
Measured: 1 day
Window quality
For each acquired window, an expert evaluated the quality of the window. The window was rated as "excellent, fair, poor, or other." "Other" captured situations where the window acquired was nondiagnostic. Window quality was dichotomized into two categories, "excellent or not excellent," and subsequent analyses examined the number of participants that acquired "excellent" windows by quadrant (perihepatic space (also called Morison's pouch or the hepatorenal recess), perisplenic space, pericardium, and the pelvis and suprapubic quadrant) and patient type (normal, positive).
Measured: 1 day
Diagnostic accuracy
For each acquired window, the participant rendered a diagnosis of that window. An expert evaluated the quality of the diagnosis. The diagnosis was rated as "correct, incorrect, or other." "Other" captured situations where the window acquired was nondiagnostic. For analysis purposes, diagnostic accuracy was dichotomized into two categories, "correct or not correct," and subsequent analyses examined the number of participants that interpreted the window correctly by quadrant (perihepatic space (also called Morison's pouch or the hepatorenal recess), perisplenic space, pericardium, and the pelvis and suprapubic quadrant) and patient type (normal, positive).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Institute of Rescue Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukasz Szarpak, National Institute of Cardiology, Warsaw, Poland
- Investigators
- Lukasz Szarpak, Principal investigator, Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289885
- Sponsor's protocol ID
- FAST/2014/02
- Acronym
- FAST
- Status last verified
- Nov 2014
- First submitted
- 7 Nov 2014
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge, Attitude and Practice About Focused Assessment With Sonography in Trauma Among Paramedics. Randomized Crossover Manikin Trial
- ClinicalTrials.gov ID
- NCT02289885
- Acronym / sponsor ID
- FAST / FAST/2014/02
- Conditions
- Trauma, Ultrasonography
- Keywords
- trauma, examination, knowledge, paramedic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- International Institute of Rescue Research and EducationUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 13 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluates the knowledge, attitude and practice about Focused Assessment with Sonography in Trauma among emergency medicine practitioners in Poland.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal model patient | Experimental | Device: SonoScapeImages of the ultrasound window were captured to disk and later evaluated by an expert in emergency medicine. In this study, the FAST examination was measured to the perihepatic space (also called Morison's pouch or the hepatorenal recess), perisplenic space, pericardium, and the pelvis. |
| ascites positive model patient | Experimental | Device: SonoScapeImages of the ultrasound window were captured to disk and later evaluated by an expert in emergency medicine. In this study, the FAST examination was measured to the perihepatic space (also called Morison's pouch or the hepatorenal recess), perisplenic space, pericardium, and the pelvis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Paramedics currently practicing in a Polish emergency department units and emergency medical services
- Age ≥ 18 years
Key exclusion criteria (1 listed)
- Inability to participate in all aspects of the study prior to study begin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SonoScapeAlso: SonoScape S6 Portable Ultrasound MachineUltrasonography device | Device | ascites positive model patient, normal model patient |
Primary outcome
Tests of Knowledge of the FAST Examination
Time frame: 1 day
knowledge-based measures used to evaluate participants' knowledge of FAST-examination-related concepts (Survey)
4 secondary outcomes
FAST Performance Test
Time frame: 1 day
Window acquisition time
Time frame: 1 day
Window quality
Time frame: 1 day
Diagnostic accuracy
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukasz Szarpak principal investigator
Institute of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SonoScape in people with Trauma and Ultrasonography, run by International Institute of Rescue Research and Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lukasz Szarpak (+48500186225, lukasz.szarpak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tests of Knowledge of the FAST Examination (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2014.